Evidence map›Paper›PMID 30269054›Full record

Trial reportAnnals of the rheumatic diseases2018

Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials.

Nicolino Ruperto, Hermine I Brunner, Pierre Quartier, Tamàs Constantin, Nico M Wulffraat, Gerd Horneff, Ozgur Kasapcopur, Rayfel Schneider, Jordi Anton, Judith Barash and 16 more

4 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 50 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00426218 phase1 / phase2completednot on this map

Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)

TypeinterventionalSponsorNovartisRan2006Enrolled26ConditionsArthritis, Juvenile RheumatoidArmsACZ885
NCT00886769 phase3terminatednot on this map

A Randomized, Double-blind, Placebo Controlled, Single-dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

TypeinterventionalSponsorNovartis PharmaceuticalsRan2009 to 2011Enrolled84ConditionsSystemic Juvenile Idiopathic ArthritisArmsCanakinumab, Placebo
NCT00889863 phase3completednot on this map

A Randomized, Double-blind, Placebo Controlled, Withdrawal Study of Flare Prevention of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

TypeinterventionalSponsorNovartis PharmaceuticalsRan2009 to 2011Enrolled177ConditionsSystemic Juvenile Idiopathic Arthritis With Active FlareArmscanakinumab, placebo
NCT00891046 phase3completednot on this map

An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever

TypeinterventionalSponsorNovartis PharmaceuticalsRan2009 to 2014Enrolled270ConditionsSystemic Juvenile Idiopathic ArthritisArmsCanakinumab
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Nicolino Ruperto *Clinica Pediatrica e Reumatologia, PRINTO, IRCCS Istituto Giannina Gaslini, Genoa, Italy nicolaruperto@gaslini.org.
Hermine I Brunner *Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Pierre QuartierCentre de référence national pour les maladies inflammatoires rhumatologiques et auto-immunes systémiques rares de l'enfant (RAISE), Unité d'Immunologie, Hématologie et Rhumatologie Pediatrique, Université Paris-Descartes, IMAGINE Institute, Hôpital Necker-Enfants Malades, Paris, France.
Tamàs Constantin2nd Department of Pediatrics, Unit of Pediatric Rheumatology-Immunology, Semmelweis University, Budapest, Hungary.
Nico M WulffraatDepartment of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, Utrecht, The Netherlands.
Gerd HorneffDepartment of General Paediatrics, Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany.
Ozgur KasapcopurDepartment of Pediatric Rheumatology, Cerrahpasa Medical School, Istanbul University, Istanbul, Turkey.
Rayfel SchneiderPediatric Rheumatology, The University of Toronto and Hospital for Sick Children, Toronto, Ontario, Canada.
Jordi AntonPediatric Rheumatology, Unidad de Reumatología Pediátrica, Esplugues de Llobregat, Hospital Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain.
Judith BarashPediatrics, Kaplan Medical Center, Rehovot, Israel.
Reinhard BernerKlinik und Poliklinik für Kinder- und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Fabrizia CoronaClinica Pediatrica De Marchi, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milano, Italy.
Ruben CutticaUnidad de Reumatología, Hospital General de Niños Pedro de Elizalde, Buenos Aires, Argentina.
Marine Fouillet-DesjonqueresService de néphrologie et rhumatologie pédiatrique, Hôpital Universitaire femme mère enfant, Groupement Hospitalier Est, Bron (Lyon), France.
Michel FischbachPédiatrie I, Hôpital Universitaire Hautepierre, Strasbourg, France.
Helen E FosterNewcastle University and Newcastle Hospitals NHS Foundation Trust, Great North Children's Hospital, Newcastle Upon Tyne, UK.
Dirk FoellUniversitätsklinikum Münster, Klinik für Pädiatrische Rheumatologie und Immunologie, Münster, Germany.
Sebastião C RadominskiCentro de estudos em terapias inovadoras, Hospital de Clínicas da UFPR, Curitiba, Brazil.
Athimalaipet V RamananDepartment of Pediatric Rheumatology Berlin, Helios Kliniken Berlin-Buch, Children's Hospital, Berlin, Germany.
Ralf TrauzeddelDepartment of Paediatric Rheumatology, Bristol Royal Hospital for Children & Royal National Hospital for Rheumatic Diseases, Bristol, UK.
Erbil UnsalDepartment of Pediatrics, Division of Pediatric Rheumatology, Dokuz Eylül University Medical Faculty, Balcova, Izmir, Turkey.
Jérémy LevyBiometrical Practice BIOP, Basel, Switzerland.
Eleni VritzaliGlobal Clinical Development, Immunology and Dermatology, Novartis Pharma AG, Basel, Switzerland.
Alberto MartiniDirezione Scientifica, IRCCS Istituto Giannina Gaslini, Genoa, Italy.
Daniel J LovellDivision of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the long-term efficacy and safety of canakinumab in patients with active systemic juvenile idiopathic arthritis (JIA).

methodsPatients (2-19 years) entered two phase III studies and continued in the long-term extension (LTE) study. Efficacy assessments were performed every 3 months, including adapted JIA American College of Rheumatology (aJIA-ACR) criteria, Juvenile Arthritis Disease Activity Score (JADAS) and ACR clinical remission on medication criteria (CR

results144 of the 177 patients (81%) enrolled in the core study entered the LTE. Overall, 75 patients (42%) completed and 102 (58%) discontinued mainly for inefficacy (63/102, 62%), with higher discontinuation rates noted in the late responders group (n=25/31, 81%) versus early responders (n=11/38, 29%). At 2 years, aJIA-ACR 50/70/90 response rates were 62%, 61% and 54%, respectively. CR

conclusionResponse to canakinumab treatment was sustained and associated with substantial glucocorticoid dose reduction or discontinuation and a relatively low retention-on-treatment rate. No new safety findings were observed on long-term use of canakinumab. TRIAL REGISTRATION NUMBERS: NCT00886769, NCT00889863, NCT00426218 and NCT00891046.

Indexed as

AdolescentAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, JuvenileChildChild, PreschoolDouble-Blind MethodFemaleHumansMaleTreatment OutcomeYoung AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic Agentscanakinumabcanakinumabclinical trialinterleukin-1βlong-term extensionsystemic juvenile idiopathic arthritis.

Identifiers

PMID30269054
PMCPMC6241618

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.